A Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid
ConditionPrimary Hyperlipidemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Ouyi Pharmaceutical Co., Ltd.
About this trial
This trial is a multicenter randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.
Eligibility criteria
Qualifiers
For participants with high risk of ASCVD: LDL-C ≥ 2.6 mmol/L (or 100 mg/dL);
For participants with extremely high risk of ASCVD: LDL-C≥ 1.8 mmol/L (or 70 mg/dL); 3) For participants with ultra-high risk of ASCVD: LDL-C≥ 1.4 mmol/L (or 55 mg/dL).
Disqualifiers
Known allergy to any component of the investigational drug or its excipients or related preparations, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.
Diagnosis with HoFH.
History of tendon diseases or tendon ruptures before the screening.
Severe, uncontrolled concomitant conditions that may affect drug absorption or have a significant impact on lipid level.
Trial design
Treatments tested in this trial
- Bempedoic Acid Tablet
- Placebo
Treatment groups
222 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov